{"id":21452,"date":"2024-09-11T09:31:39","date_gmt":"2024-09-11T15:31:39","guid":{"rendered":"https:\/\/limblecmms.com\/?p=21452"},"modified":"2025-05-30T13:00:45","modified_gmt":"2025-05-30T19:00:45","slug":"21-cfr-part-11","status":"publish","type":"post","link":"https:\/\/limblecmms.com\/blog\/21-cfr-part-11\/","title":{"rendered":"Understanding 21 CFR part 11: are you compliant?"},"content":{"rendered":"<p><span style=\"font-weight: 400;\">In some industries, a defective product can only seriously harm the organization producing it. When quality starts to slip, proactive maintenance teams can spring into action to make a fix, idling keeping downtime and its costs to a minimum.\u00a0<\/span><\/p>\n<p><span style=\"font-weight: 400;\">For industries like the <\/span><a href=\"https:\/\/limblecmms.com\/industry\/healthcare-hospital-maintenance-software\/\"><span style=\"font-weight: 400;\">pharmaceutical and medical defective sectors<\/span><\/a><span style=\"font-weight: 400;\">, however, a defective product can do much worse than disappoint a customer or bring production to a brief halt. These products can hurt or even kill customers if they fail to meet rigorous quality standards.\u00a0<\/span><\/p>\n<p><span style=\"font-weight: 400;\">That\u2019s why the Food and Drug Administration imposes regulations on the organizations under its management. These hold organizations accountable, promote product quality, and help guide the FDA when it needs to investigate incidents to identify their root cause.\u00a0<\/span><\/p>\n<h3><b>21 CFR explained<\/b><\/h3>\n<p><a href=\"https:\/\/limblecmms.com\/maintenance-definitions\/21-cfr\/\"><span style=\"font-weight: 400;\">21 CFR<\/span><\/a><span style=\"font-weight: 400;\"> is the common name for Title 21 of the Code of Federal Regulations. The term refers to a broad range of requirements an FDA-regulated organization must meet to ensure its products are safe and effective.<\/span><\/p>\n<p><span style=\"font-weight: 400;\">Of 21 CFR\u2019s many sections, two are especially relevant to maintenance teams. An appropriately proactive and strategic approach to managing assets and facilities will simplify compliance with 21 CFR Parts 11 and 820.\u00a0<\/span><b><\/b><\/p>\n<ul>\n<li aria-level=\"1\"><b>Part 11 \u2013 Electronic Records and Electronic Signatures\u00a0<\/b><\/li>\n<li aria-level=\"1\"><a href=\"https:\/\/limblecmms.com\/blog\/complying-with-21-cfr-part-820\/\"><b>Part 820 \u2013 Quality System Regulation (QSR)<\/b><\/a><\/li>\n<\/ul>\n<h2><span style=\"font-weight: 400;\">What is 21 CFR Part 11?\u00a0<\/span><\/h2>\n<p><span style=\"font-weight: 400;\">Part 11 of 21 CFR includes requirements for ensuring the safety and reliability of electronic signatures and record-keeping processes. In addition to protecting sensitive data, the regulations help organizations to minimize their use of paper by ensuring digital documents offer equivalent security.\u00a0<\/span><\/p>\n<p><span style=\"font-weight: 400;\">This section also deals with software solutions used to manufacture, store, and test pharmaceuticals and regulated products. All systems must be validated appropriately. Validation is not a one-time initiative, but an ongoing process to ensure systems never deviate from their intended purpose or fail to produce accurate records.\u00a0<\/span><\/p>\n<h2><span style=\"font-weight: 400;\">21 CFR compliance checklist\u00a0<\/span><\/h2>\n<p><span style=\"font-weight: 400;\">Need help conducting an internal review? This handy checklist should make it simple to grade your operations against 21 CFR\u2019s requirements and, if necessary, address sources of non-compliance.\u00a0<\/span><\/p>\n<h4><span style=\"font-weight: 400;\">Do you meet 21 CFR Part 11\u2019s validation requirements?\u00a0<\/span><\/h4>\n<ul>\n<li style=\"font-weight: 400;\" aria-checked=\"false\" aria-level=\"1\"><span style=\"font-weight: 400;\">Our current system is validated and all of the approved validation documents are easily accessible.\u00a0<\/span><\/li>\n<li style=\"font-weight: 400;\" aria-checked=\"false\" aria-level=\"1\"><span style=\"font-weight: 400;\">We can recognize invalid records or records that have been altered.\u00a0<\/span><\/li>\n<li style=\"font-weight: 400;\" aria-checked=\"false\" aria-level=\"1\"><span style=\"font-weight: 400;\">Our records are easy to retrieve throughout their retention period.\u00a0<\/span><\/li>\n<li style=\"font-weight: 400;\" aria-checked=\"false\" aria-level=\"1\"><span style=\"font-weight: 400;\">Our system limits access to authorized personnel.\u00a0<\/span><\/li>\n<li style=\"font-weight: 400;\" aria-checked=\"false\" aria-level=\"1\"><span style=\"font-weight: 400;\">Our system includes user-based permissions for features like signing or altering records.\u00a0<\/span><\/li>\n<li style=\"font-weight: 400;\" aria-checked=\"false\" aria-level=\"1\"><span style=\"font-weight: 400;\">Our system enforces process control.\u00a0<\/span><\/li>\n<li style=\"font-weight: 400;\" aria-checked=\"false\" aria-level=\"1\"><span style=\"font-weight: 400;\">We have documented training processes for employees who use the system.\u00a0<\/span><\/li>\n<\/ul>\n<p><span style=\"font-weight: 400;\">Do you meet 21 CFR Part 11\u2019s requirements for audit trails?\u00a0<\/span><\/p>\n<ul>\n<li style=\"font-weight: 400;\" aria-checked=\"false\" aria-level=\"1\"><span style=\"font-weight: 400;\">Our system includes version control.\u00a0<\/span><\/li>\n<li style=\"font-weight: 400;\" aria-checked=\"false\" aria-level=\"1\"><span style=\"font-weight: 400;\">Our audit trail is accessible throughout the record\u2019s retention period.\u00a0<\/span><\/li>\n<li style=\"font-weight: 400;\" aria-checked=\"false\" aria-level=\"1\"><span style=\"font-weight: 400;\">Our signed records include the following information:\u00a0<\/span><\/li>\n<li style=\"font-weight: 400;\" aria-checked=\"false\" aria-level=\"1\"><span style=\"font-weight: 400;\">The name of the signer<\/span><\/li>\n<li style=\"font-weight: 400;\" aria-checked=\"false\" aria-level=\"1\"><span style=\"font-weight: 400;\">The date and time of the signing<\/span><\/li>\n<li style=\"font-weight: 400;\" aria-checked=\"false\" aria-level=\"1\"><span style=\"font-weight: 400;\">The type of signing (approval, review, etc.)<\/span><\/li>\n<li style=\"font-weight: 400;\" aria-checked=\"false\" aria-level=\"1\"><span style=\"font-weight: 400;\">This information is displayed on all copies of the electronic record.<\/span><\/li>\n<li style=\"font-weight: 400;\" aria-checked=\"false\" aria-level=\"1\"><span style=\"font-weight: 400;\">Electronic signatures are unique to specific individuals.\u00a0<\/span><\/li>\n<li style=\"font-weight: 400;\" aria-checked=\"false\" aria-level=\"1\"><span style=\"font-weight: 400;\">Our change control procedure for system documentation includes its own audit trail for all changes.\u00a0\u00a0<\/span><\/li>\n<\/ul>\n<p><b>Record retention<\/b><\/p>\n<ul>\n<li style=\"font-weight: 400;\" aria-checked=\"false\" aria-level=\"1\"><span style=\"font-weight: 400;\">User passwords periodically expire.\u00a0<\/span><\/li>\n<\/ul>\n<h2><span style=\"font-weight: 400;\">Tips for 21 CFR Part 11 compliance<\/span><\/h2>\n<p><a href=\"https:\/\/limblecmms.com\/blog\/10-tips-for-passing-21-cfr-audits\/\"><span style=\"font-weight: 400;\">Enhance your audit preparedness<\/span><\/a><span style=\"font-weight: 400;\"> with these best practices for strategic, forward-looking maintenance and document management.\u00a0\u00a0<\/span><\/p>\n<ol>\n<li style=\"font-weight: 400;\" aria-level=\"1\"><b>Keep your records organized and detailed<\/b><span style=\"font-weight: 400;\">: Whether you\u2019ve got a <\/span><a href=\"https:\/\/limblecmms.com\/cmms\/\"><span style=\"font-weight: 400;\">Computerized Maintenance Management System (CMMS)<\/span><\/a><span style=\"font-weight: 400;\">, a spreadsheet, or packed filing cabinets, ensure relevant records are always easily accessible and appropriately formatted. Never skimp on detail related to your maintenance and quality control activities.\u00a0<\/span><\/li>\n<li style=\"font-weight: 400;\" aria-level=\"1\"><b>Build a strong training program<\/b><span style=\"font-weight: 400;\">: Personnel from across your maintenance department have a role to play in keeping your organization compliant with FDA regulations. Ensuring they understand all relevant policies and procedures will keep them prepared to execute their duties.\u00a0<\/span><\/li>\n<li style=\"font-weight: 400;\" aria-level=\"1\"><b>Review and update your standard operating procedures<\/b><span style=\"font-weight: 400;\">: Your SOPs should be dynamic documents, evolving to reflect current requirements and best practices. Regular assessments and updates will ensure you\u2019ve got the right workflows in place and can always stay prepared.\u00a0<\/span><\/li>\n<li style=\"font-weight: 400;\" aria-level=\"1\"><b>Conduct random audits:<\/b><span style=\"font-weight: 400;\"> Proactively assessing your operations could help you identify potential compliance issues well ahead of time to address them before FDA investigators come knocking.\u00a0<\/span><\/li>\n<\/ol>\n<h2><span style=\"font-weight: 400;\">Download our 21 CFR compliance kit<\/span><\/h2>\n<p><span style=\"font-weight: 400;\">Meeting Part 11\u2019s requirements is just one part of staying 21 CFR compliant. Our downloadable compliance kit includes more checklists and resources to ensure you meet every requirement and take the stress out of regulations. You can even download the document and customize it to your organization\u2019s unique systems and assets. <\/span><a href=\"https:\/\/limblecmms.com\/resources\/21-cfr-compliance-toolkit\/\"><span style=\"font-weight: 400;\">Check it out<\/span><\/a><span style=\"font-weight: 400;\">.\u00a0<\/span><\/p>\n<h2><span style=\"font-weight: 400;\">Simplify and digitize 21 CFR compliance<\/span><\/h2>\n<p><span style=\"font-weight: 400;\">FDA-regulated companies trust Limble to help them <\/span><a href=\"https:\/\/limblecmms.com\/solutions\/compliance\/\"><span style=\"font-weight: 400;\">pass audits<\/span><\/a><span style=\"font-weight: 400;\"> with ease and stay in compliance with 21 CFR.\u00a0<\/span><\/p>\n<ul>\n<li style=\"font-weight: 400;\" aria-level=\"1\"><span style=\"font-weight: 400;\">Every Limble user has unique login credentials and users can configure platform settings to ensure passwords meet security standards.\u00a0<\/span><\/li>\n<li style=\"font-weight: 400;\" aria-level=\"1\"><span style=\"font-weight: 400;\">Limble offers access control with more than 200 unique permissions.\u00a0<\/span><\/li>\n<li style=\"font-weight: 400;\" aria-level=\"1\"><span style=\"font-weight: 400;\">Maintenance and asset performance history data are automatically stored with crucial info like assigned personnel and timestamps.\u00a0<\/span><\/li>\n<li style=\"font-weight: 400;\" aria-level=\"1\"><span style=\"font-weight: 400;\">Once users create preventive maintenance schedules they can automate task creation and store records of completed work.\u00a0<\/span><\/li>\n<li style=\"font-weight: 400;\" aria-level=\"1\"><span style=\"font-weight: 400;\">Approval requests and other workflows include an electronic signature feature.\u00a0<\/span><\/li>\n<\/ul>\n<h4><b>Hear what Spectrum Solutions says about Limble<\/b><\/h4>\n<p><span style=\"font-weight: 400;\">When the COVID-19 pandemic hit, Spectrum Solutions was the very first organization to obtain Emergency Use Authorization to produce saliva-based tests. With such a high-impact workload, they could not afford to fail an audit and experience shutdowns. An error-prone, antiquated system tended to make audits stressful, inspiring them to pursue a CMMS.\u00a0<\/span><\/p>\n<p><span style=\"font-weight: 400;\">Limble quickly emerged as the ideal candidate to support daily maintenance needs and streamline audit preparation. The platform offers a single source of truth which has so far made it possible to satisfy FDA investigators more quickly than ever.\u00a0<\/span><\/p>\n<p><a href=\"https:\/\/limblecmms.com\/case-study\/spectrum-solutions\/\"><span style=\"font-weight: 400;\">Check out the full case study from Spectrum<\/span><\/a><span style=\"font-weight: 400;\"> and learn more about Limble\u2019s compliance-promoting features in our guide to <\/span><a href=\"https:\/\/help.limblecmms.com\/en\/articles\/5581493-21-cfr-faqs\"><span style=\"font-weight: 400;\">21 CFR and CMMS FAQs<\/span><\/a><span style=\"font-weight: 400;\">.<\/span><\/p>\n","protected":false},"excerpt":{"rendered":"<p>In some industries, a defective product can only seriously harm [&hellip;]<\/p>\n","protected":false},"author":77,"featured_media":0,"comment_status":"closed","ping_status":"closed","sticky":false,"template":"","format":"standard","meta":{"_acf_changed":false,"footnotes":""},"categories":[736],"tags":[],"class_list":["post-21452","post","type-post","status-publish","format-standard","hentry","category-compliance-safety"],"acf":[],"yoast_head":"<!-- This site is optimized with the Yoast SEO Premium plugin v25.7.1 (Yoast SEO v25.7) - https:\/\/yoast.com\/wordpress\/plugins\/seo\/ -->\n<title>Are You 21 CFR Part 11 Compliant? 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